Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD

NCT03889392 | Completed

• 1 other identifier: 2019-0310
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

ADPKD is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the U.S. ADPKD consists of 2.8% of patients receiving kidney transplantation in the investigator's center. It is known that ADPKD is associated with vascular anomalies, including abdominal aneurysms, valvular anomalies and especially intracranial aneurysms. Intracranial aneurysms occur in 9\~12% of the ADPKD population which is higher than 2\~3% in the general population and is known to be associated with PKD1 or PKD2 heritage. Until now, most of the studies regarding intracranial aneurysms in ADPKD are conducted in animal models, and there are only few cellular studies conducted from human samples. Total 154 patients received kidney transplantation for ADPKD from 1994 to December 2018 at Asan Medical Center, Seoul, Korea. While performing kidney transplantation to ESRD ADPKD patients, nephrectomy has been routinely performed for polycystic kidney and the nephrectomy specimens can be obtained. The objective of this study is to investigate the mechanism of intracranial aneurysm in ADPKD patients by analyzing gene characteristics from nephrectomy specimens.

Conditions

Kidney Transplant; Complications; Aneurysm, Brain; Polycystic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Intracranial aneurysm

  Occurrence of intracranial aneurysm

  average of 5 years

Study Arms (1)

polycystic kidney disease

Adult autosomal dominant polycystic kidney disease patients who received kidney transplantation at Asan Medical Center between 1994 and 2018

Procedure: Kidney transplantation and nephrectomy

Interventions

Kidney transplantation and nephrectomy PROCEDURE

Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients

polycystic kidney disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients between age 18 and 80, Patients who received kidney transplantation for ADPKD at Asan Medical Center between 1994 and 2018, Patients who received nephrectomy for polycystic kidney

You may qualify if:

• Adult patients between age 18 and 80,
• Patients who received kidney transplantation for ADPKD at Asan Medical Center between 1994 and 2018,
• Patients who received nephrectomy for polycystic kidney

You may not qualify if:

• those who refuse or are unable to provide consent form,
• pregnancy

Sponsors & Collaborators

• Asan Medical Center: lead

Related Publications (4)

• Iglesias CG, Torres VE, Offord KP, Holley KE, Beard CM, Kurland LT. Epidemiology of adult polycystic kidney disease, Olmsted County, Minnesota: 1935-1980. Am J Kidney Dis. 1983 May;2(6):630-9. doi: 10.1016/s0272-6386(83)80044-4.

  PMID: 6846334 BACKGROUND

• Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. 'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012 Jan;59(1 Suppl 1):A7, e1-420. doi: 10.1053/j.ajkd.2011.11.015. No abstract available.

  PMID: 22177944 BACKGROUND

• Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.

  PMID: 17434405 BACKGROUND

• Ecder T, Schrier RW. Cardiovascular abnormalities in autosomal-dominant polycystic kidney disease. Nat Rev Nephrol. 2009 Apr;5(4):221-8. doi: 10.1038/nrneph.2009.13.

  PMID: 19322187 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

polycystic kidney specimen from nephrectomy operation during kidney transplantation

MeSH Terms

Conditions

Intracranial Aneurysm; Polycystic Kidney Diseases

Interventions

Kidney Transplantation; Nephrectomy

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: January 1, 1994
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03